"Hypoglycaemia is an ongoing challenge for people with type 1 and type 2 diabetes," said Dr. Wendy Lane, lead SWITCH 1 study investigator and clinical endocrinologist at Mountain Diabetes and Endocrine Center in Asheville, N.C., U.S. "These findings are important for the diabetes community, and add to the existing body of evidence for Tresiba®."

The two phase 3b, 2x32-weeks randomised, double-blind, crossover, treat-to-target trials were initiated in January 2014 to compare the safety profile and efficacy of Tresiba® and insulin glargine U-100. The overall objective was to document the hypoglycaemia profile in type 1 diabetes and type 2 diabetes, respectively. During the maintenance period, the primary endpoint studied was the number of treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes. The two secondary endpoints included: the number of treatment emergent severe or BG confirmed nocturnal episodes and the proportion of subjects with one or more severe hypoglycaemic episodes. In SWITCH 1, 501 people with type 1 diabetes were randomised to crossover treatment with Tresiba® and insulin glargine U-100 in combination with insulin aspart. In SWITCH 2, 721 people with type 2 diabetes were randomised to crossover treatment with Tresiba® and insulin glargine U-100 in combination with oral antidiabetic drugs.

About hypoglycaemia

Hypoglycaemia is a frequent complication in people with type 1 and type 2 diabetes when low levels of blood glucose in the blood deprive muscles, cells and the brain of the energy needed to function.6 Hypoglycaemia can be triggered by multiple factors including taking too much insulin, not following the prescribed meal schedule or participating in unusually strenuous or prolonged exercise.

About Tresiba®

Tresiba® (insulin degludec injection U-100) is a once-daily basal insulin that provides a duration of action beyond 42 hours.7,8 It is important for people with type 1 and type 2 diabetes to establish a routine for insulin treatment. On occasions when administration at the same time of day is not possible, Tresiba® allows for flexibility in day-to-day dosing time when needed.7,9,10 Tresiba® received its first regulatory approval in September 2012 and has since been approved in more than 60 countries globally. It was most recently approved by the FDA in the United States on 26 September 2015.